Hutchmed China announced on Monday that the “pivotal” global phase three trial evaluating the investigational use of ‘fruquintinib’ met its primary endpoint of overall survival in patients with advanced, refractory metastatic colorectal cancer (CRC).
The AIM-traded firm described FRESCO-2 as a multi-regional clinical trial conducted in the US, Europe, Japan and Australia, that investigated fruquintinib plus “best supportive care” (BSC), versus placebo plus BSC in patients with metastatic CRC who had progressed on standard chemotherapy, and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 or regorafenib.
In addition to OS, a “statistically-significant” improvement in progression-free survival, a key secondary endpoint, was observed.
The safety profile of fruquintinib in FRESCO-2 was consistent with previously-reported studies, while full results would be submitted for presentation at an upcoming medical meeting.
Hutchmed said it had been in communication with regulatory agencies globally regarding the FRESCO-2 trial design and conduct, and would discuss that data with agencies in the US, Europe and Japan with the intent to submit marketing authorisation applications as soon as possible.
The US Food and Drug Administration (FDA) granted ‘fast track designation’ for the development of fruquintinib for the treatment of patients with metastatic CRC in June 2020.
“We are very happy to see the positive outcomes of the FRESCO-2 study which offers a potential new treatment for patients with advanced metastatic colorectal cancer, where the unmet need is very high and patients have limited treatment options,” said Dr Marek Kania, executive vice-president, managing director and chief medical officer of Hutchmed International..
“Results from the global FRESCO-2 study supplement findings from the original FRESCO study that led to the marketing approval and commercialization of fruquintinib in China.
“We would like to thank the patients, their families, and the healthcare professionals who participated in this study and helped achieve this important milestone.”
Dr Weiguo Su, chief executive officer and chief scientific officer of Hutchmed, added that the company was pleased to have successfully completed its first multi-regional clinical trial to support the global registration of fruquintinib.
“It has already benefited patients with advanced CRC in China since its launch in 2018,” Dr Su said.
“It is also being evaluated alone and in combination with other agents in various tumour types in ongoing studies around the world.”
Hutchmed said it retained all commercial rights to fruquintinib outside of China.
In China, where fruquintinib was marketed under the brand name ‘Elunate’, Hutchmed had partnered with Eli Lilly and was responsible for development and execution of all on-the-ground medical detailing, promotion and local and regional marketing.
Fruquintinib is currently not approved for use outside of China.
At 1157 BST, shares in Hutchmed China were up 6.36% at 234p.